FDA denies a Vanda petition asking that it not approve an ANDA for Fanapt until expiration of a three-year exclusivity relating to the companys REPRIE...
President-elect Donald Trump selects House Budget Committee chair Tom Price (R-GA) to serve as HHS secretary in the next administration.
E-mails obtained through the Freedom of Information Act by MobiHealthNews show a lengthy relationship between FDA and Apple on a number of medical dev...
FDA warns Chinas Dongying Tiandong Pharmaceutical Co. about CGMP violations in its production of active pharmaceutical ingredients, especially heparin...
FDAs Philadelphia District Office warns STI Pharma about postmarketing adverse drug experience reporting violations involving two NDAs and five ANDAs....
The latest FDA report on the status of drug postmarketing requirements and commitments shows that industry has improved its (on-time) submission of an...
CBER sends San Diego-based Dr. PRP America an untitled letter over the unapproved marketing of its medical device Dr. PRP Kit for Platelet Rich Plasma...
CDER issues a MAPP on a new Safety Outcomes Trials subcommittee under the Medical Policy Council.